IT / CSV Consultant

mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.

Job Description :

The professional will be responsible for supporting project execution and documentation within a GMP-regulated environment, ensuring alignment with IT and CSV compliance standards. Key deliverables include :

• Review project documentation to ensure compliance with IT and CSV procedures; communicate findings and resolve discrepancies in a timely manner.
• Provide technical expertise and guidance related to GMP requirements throughout the project lifecycle.
• Own, review, and approve Validation and CSV documentation, including deviation classification and completion of impact assessments, as applicable.
• Ensure the accurate and proper completion of all required project documentation to support validation and regulatory compliance.
• Actively participate in MLUP project meetings, offering insight and updates related to documentation and compliance.
• Review and revise Standard Operating Procedures (SOPs) as needed; approve document updates according to change control requirements.
• Provide coaching, support, and feedback on IT, CSV, and GMP compliance to relevant team members.
• Promote and support a culture of continuous improvement and operational excellence through the implementation of best practices and process enhancements.
• Support change control initiatives by ensuring documentation and execution align with regulatory expectations.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.